NI

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS BACKFLOW OF BLOOD PRODUCT DURING USE OF AN UNSPECIFIED ACCESS SET. THE ISSUE WAS IDENTIFIED DURING START OF A BLOOD TRANSFUSION ON AN INFUSION PUMP. BLOOD APPEARED TO BE FLOWING BACK AND NO DROPS WERE NOTED IN CHAMBER. THE TRANSFUSION DID COMPLETE; HOWEVER, IT WAS NOT SPECIFIED IF THE TUBING WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.